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Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection

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ClinicalTrials.gov Identifier: NCT01941238
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Reem Mohammad Alamoudi, King Abdullah International Medical Research Center

Brief Summary:

Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan

The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.


Condition or disease
Type 1 Diabetes

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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi-dose Insulin Injection
Study Start Date : July 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Insulin pump
MDI



Primary Outcome Measures :
  1. Incidence of hypoglycemia [ Time Frame: 5 weeks ]
    Rates of hypoglycemia during fasting ramadan in insulin pump users and MDI users [Hypoglycemia defined as blood glucose level ≤ 70 mg/dl ( 3.9 mmol/l)]


Secondary Outcome Measures :
  1. Number of fasting days lost [ Time Frame: 5 weeks ]
    To estimate the number of days they needed to brake their fast due to acute complications (hypoglycemia, severe hyperglycemia, or DKA).

  2. Glycemic control [ Time Frame: Two (2) months ]
    To assess the glycemic control in the two groups using HbA1c and Fructosamine assays.

  3. overnight hypoglycemia [ Time Frame: 5 weeks ]
    To estimate the rates of overnight hyperglycemia in both groups.

  4. Rate of acute complications [ Time Frame: 5 weeks ]
    To estimate presence of severe hyperglycemia and /or DKA episodes in both groups



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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population of our study is all patients with type1DM treated at three National Guard institutiuons in three different cities of Saudi Arabia (Riyadh, Alahsa, Dammam) with either insulin pump or MDI
Criteria

Inclusion Criteria:

  1. DM type 1
  2. Age ≥14 years
  3. Patients on insulin pump (more than 3 months)
  4. Patients on MDI (glargine or detemir combined with aspart or lispro) regimen
  5. Diagnosis of type 1 DM of more than 6 months.
  6. Willing to do Self Monitoring Blood Sugar (SMBG)
  7. Have no other contraindication to fast

Exclusion Criteria:

  1. Patient with renal or hepatic impairment
  2. Patient with diagnosed adrenal insufficiency
  3. Pregnancy
  4. Alcoholism
  5. Any diagnosed psychiatric disease
  6. Can not do SMBG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941238


Locations
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Saudi Arabia
National Guards Hospital
Dammam, Saudi Arabia, 31412
Sponsors and Collaborators
Reem Mohammad Alamoudi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Reem Mohammad Alamoudi, Consultant Endocrinology, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT01941238     History of Changes
Other Study ID Numbers: RE12-002
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Reem Mohammad Alamoudi, King Abdullah International Medical Research Center:
Ramadan
Fasting
Diabetes
Type1
Insulin
Pump
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs